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510(k) Data Aggregation
(154 days)
The Pantheris LV System is indicated to remove plaque (atherectomy) from partially occluded native or restenotic vessels, including in-stent restenosis (ISR), in the peripheral vasculature with a reference diameter of 3.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures, and vessel morphologies. The Pantheris LV System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.
The Pantheris LV catheter combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular atherectomy capabilities. The Pantheris LV System consists of the Pantheris LV catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and the Lightbox Imaging Console (referred to as "Lightbox"). The Pantheris LV catheter is a 7 French device with a working length of 110 cm. It is comprised of two components-an outer support catheter and an inner assembly or drive shaft. It is provided sterile and is a single-use device compatible with 5 Fr vascular sheaths. The Pantheris LV catheter incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCT-guided atherectomy during the procedure with its connection to the Lightbox.
This document is a 510(k) summary for the Pantheris LV Atherectomy Catheter. It outlines the device's indications for use, compares it to predicate and reference devices, and describes the performance data used to demonstrate substantial equivalence.
Based on the provided text, the Pantheris LV Atherectomy Catheter is not an AI/ML enabled device. This conclusion is drawn from the following observations:
- Absence of AI/ML terminology: The document does not mention any terms typically associated with AI or machine learning, such as "algorithm," "model," "deep learning," "neural network," "AI assistance," "inference," "training data," "validation data," "ground truth establishment" for algorithms, or "performance metrics" relevant to AI (e.g., sensitivity, specificity, AUC for an AI-driven diagnostic).
- Focus on mechanical and optical characteristics: The device description and performance data sections primarily detail mechanical properties, optical coherence tomography (OCT) imaging capabilities (which are optical imaging not AI-driven image interpretation), electrical safety, electromagnetic compatibility, and biocompatibility.
- Comparison to existing devices based on physical design: The substantial equivalence argument relies heavily on comparing the Pantheris LV's physical design attributes (e.g., catheter size, tip length, working length, mechanism of atherectomy) and shared operational characteristics with existing cleared devices, rather than any advanced computational functionalities.
- Nature of the device: The device is described as an "atherectomy catheter" used to "remove plaque." Its functionality involves physical plaque removal assisted by OCT imaging for guidance, not AI-driven diagnosis, interpretation, or decision-making. The OCT is explicitly stated as "OCT-assisted orientation and imaging" and "an adjunct to fluoroscopy by providing images of vessel lumen, wall structures, and vessel morphologies," referring to human interpretation of these images, not AI analysis of them.
- Lack of AI-specific study types: The "Performance Data" section details mechanical, electrical, and biocompatibility testing. There is no mention of studies that would be typical for an AI/ML device, such as those evaluating diagnostic accuracy (e.g., standalone performance, MRMC studies, reader studies). The sections on "Animal Testing" and "Clinical Studies" explicitly state they "were not necessary" for this particular submission, further indicating the absence of complex data-driven (AI) performance validation.
Therefore, the request to describe acceptance criteria and study data for an AI/ML device is not applicable to the Pantheris LV Atherectomy Catheter based on this document. The provided text does not contain information related to AI/ML acceptance criteria or studies.
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(139 days)
The Pantheris System is intended to remove plaque (atherectomy) from partially occluded native or restenotic vessels, including in-stent restenosis (ISR), in the peripheral vasculature with a reference diameter of 3.0 mm to 7.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures, and vessel morphologies. The Pantheris system is not intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.
The Pantheris System consists of a Pantheris atherectomy catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and a Lightbox HS Imaging Console (referred to as "Lightbox"). The Pantheris atherectomy catheter is a 7 French device with a working length of 110 cm. It incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCT-guided atherectomy during the procedure with its connection to the Lightbox via the Sled accessory.
The following provides an analysis of the acceptance criteria and study findings for the Pantheris System, based on the provided FDA 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Endpoint | Acceptance Criteria (Performance Goal) | Reported Device Performance (Pantheris System) |
|---|---|---|
| Primary Safety: Freedom from Major Adverse Events (MAE) at 30 days | MAEs occurring in < 20% of subjects | 97% freedom from MAEs (3% experienced MAE); 95% one-sided upper confidence bound of 6.5%. Met. |
| Secondary Safety: Absence of new or worsening stent fracture | Not established with a sample size requirement; extremely low incidence expected | 1% (1 out of 97 procedures) inadvertently made contact with a stent. Met (due to low incidence and subsequent physician retraining efficacy). |
| Primary Effectiveness: Technical Success (residual stenosis ≤ 50% post-Pantheris alone) | > 79% | 89% (86 out of 97 subjects) had <50% residual stenosis; 95% one-sided upper confidence bound of 95% and lower confidence bound of 82%. Met. |
| Secondary Effectiveness (Powered): Freedom from Target Lesion Revascularization (TLR) at 6 months | > 61% | 93% (79 out of 85 subjects) freedom from TLR; 95% one-sided upper confidence bound of 98% and lower bound of 87%. Met. |
| Secondary Effectiveness: Procedural Success (residual stenosis ≤ 30% post-Pantheris + adjunctive therapy) | Not explicitly defined as a performance goal with a specific threshold. | 80% (78 out of 97 subjects) had residual stenosis < 30%; mean stenosis of 15% ± 10.1%. |
| Secondary Effectiveness: Change in Ankle-Brachial Index (ABI) | Not explicitly defined as a performance goal with a specific threshold. | ABI improved 39% from baseline at 6 months. |
| Secondary Effectiveness: Change in Rutherford Classes | Not explicitly defined as a performance goal with a specific threshold. | Rutherford Classification improved 71% at 6 months. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A total of 97 subjects were enrolled in the INSIGHT trial.
- Data Provenance: The study was a prospective, multi-center trial conducted across 17 investigational sites in the USA (n=15) and EU (n=2). Therefore, the data is prospective and from both the US and Europe.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document specified that the primary safety endpoint (freedom from MAEs) was adjudicated by an independent Clinical Events Committee (CEC).
- The primary effectiveness endpoint (technical success) and secondary effectiveness endpoint (procedural success) involving residual diameter stenosis were assessed by an independent angiographic core laboratory.
- The specific number or qualifications of experts within the CEC or the core laboratory are not detailed in this summary.
4. Adjudication Method for the Test Set
- For the primary safety endpoint (MAEs), an independent Clinical Events Committee (CEC) was used for adjudication. The specific method (e.g., 2+1, 3+1) is not provided, but the independence suggests a standardized, expert-driven review process.
- For effectiveness endpoints related to stenosis, an independent angiographic core laboratory assessed the outcomes. This implies multiple expert readers are likely involved in standardized image analysis, but the exact adjudication method is not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was reported. The study focused on the performance of the Pantheris System itself, a medical device for atherectomy, not an AI-assisted diagnostic or interpretative system.
6. Standalone Performance
- The study was a "single-arm trial" to determine the safety and performance outcomes of the Pantheris System.
- The primary effectiveness endpoint specifically refers to "residual diameter stenosis ≤ 50% after use of the Pantheris device alone," indicating that standalone performance (algorithm only without human-in-the-loop performance) was assessed for this specific aspect of effectiveness, meaning the intervention of the device itself.
- The "algorithm" in this context refers to the device's mechanism of action, as it's an atherectomy system, not a software-based AI algorithm.
7. Type of Ground Truth Used
- Clinical Outcomes: The ground truth relied on direct clinical outcomes assessed during the study, including:
- Occurrence of Major Adverse Events (MAEs).
- Angiographic measurements of residual stenosis (assessed by an independent core lab).
- Target Lesion Revascularization (TLR) rates.
- Changes in physiological markers (ABI) and clinical classification (Rutherford Classes).
- Expert Adjudication: For MAEs and angiographic assessments, the "ground truth" was established by expert adjudication (independent CEC and independent angiographic core laboratory).
- Histopathology/Pathology: For preclinical animal studies, pathology (light microscopy, radiography, and SEM) was used to assess acute treatment effects on arteries and stents.
8. Sample Size for the Training Set
- The document describes a clinical trial (INSIGHT Trial) which is a clinical validation study for expanded indications, not a training set for an AI algorithm.
- No training set for an AI algorithm is mentioned as the device is a physical atherectomy system, not an AI diagnostic tool.
9. How the Ground Truth for the Training Set Was Established
- As the device is an atherectomy system and not an AI algorithm, there is no mention of a "training set" or "ground truth for a training set" in the context of machine learning. The clinical trial data serves as validation for the device's performance against pre-defined clinical endpoints.
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(224 days)
The Pantheris SV is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 2.0 mm to 4.0 mm, using OCTassisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies. The Pantheris SV is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.
The Pantheris SV catheter is a monorail (rapid exchange) device with a working length of 144 cm, compatible with a 6 French sheath and an 0.014" guidewire. It consists of a lubricious coated torque shaft with a proximal handle assembly and an atraumatic distal assembly. The distal assembly of the catheter consists of an imaging assembly, a rotating cutter, and a flexible, tiltable nosecone. The catheter is sterilized by electron beam radiation and is intended for single use only. The Pantheris SV is to be used in a healthcare facility, such as a cardiac catheter lab or a hospital. It is to be used and in contact with patient tissue for less than 24 hours and is made of materials that are biocompatible.
This document is a 510(k) summary for the Pantheris SV atherectomy catheter. It describes the device, its intended use, and compares it to a predicate device and a reference device. It also details the non-clinical performance data supporting the device's substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a tabular format for each test. Instead, it states that the device "passed all tests" or that parameters were "ranked from 'good' to 'excellent'." No specific quantitative acceptance values are provided, as this is a 510(k) submission focused on substantial equivalence rather than a detailed performance study with pre-defined statistical endpoints for a new technology.
However, based on the Mechanical Testing and Animal Testing sections, we can infer some performance indicators:
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Biocompatibility standards met | Passed all ISO 10993 tests (Cytotoxicity, Sensitization, Irritation, Material-mediated pyrogenicity, Systemic toxicity, Complement activation, Partial thromboplastin time, Platelet and leukocyte count, Hemolysis extract, Hemolysis direct) |
| Electrical safety standards met | Complies with IEC 60601-1 |
| Electromagnetic compatibility (EMC) standards met | Complies with IEC 60601-1-2 |
| Software Verification & Validation | Successfully upgraded to version 4.4.0 (for Lightbox console) |
| Mechanical integrity (e.g., Simulated use, working length, flush & leak, image generation, rotation, guidewire compatibility, insertion force, retraction force, cutter exposure, full 360° image, cut/pack cycles, coating integrity, life cycle, torque-proof loading, tensile strengths, functionality performance) | All mechanical tests performed at time 0 and 3 months. Implied successful completion as no issues are reported. |
| Animal study safety | No significant procedural adverse events, no evidence of acute vessel trauma, no evidence of thrombus, no tissue reaction (gross necropsy and histopathology). |
| Animal study performance (tracking, advancement, OCT clarity, orientation, MEFR) | All treatment evaluation parameters and MEFR evaluations ranked from "good" to "excellent." No thrombus visualized, no device failures. |
2. Sample Size Used for the Test Set and Data Provenance
- Mechanical Testing: The document does not specify the exact sample size (number of catheters/units) used for each mechanical test. It lists the types of tests conducted.
- Animal Testing: Two pigs were enrolled in this study.
- Data Provenance: The study was a GLP (Good Laboratory Practice) animal study. While the country isn't explicitly stated, GLP studies are typically highly regulated, and the context of an FDA submission suggests it was conducted under U.S. or comparable international standards. It is a prospective study for the purpose of demonstrating safety and performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For the animal study, the document mentions "gross necropsy and histopathology" which would typically involve qualified veterinary pathologists. However, the number of experts or their specific qualifications (e.g., board-certified veterinary pathologist with X years of experience) are not specified in this summary. The ranking of treatment evaluation parameters from "good" to "excellent" implies expert assessment, but the details are missing.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the animal study or mechanical testing. Given the summary's content, it's likely that a single expert or a team within the company assessed the results of the animal study, but no formal adjudication process (like 2+1 or 3+1 consensus) is outlined.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical testing of the subject device was necessary." The testing involved mechanical and animal studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The Pantheris SV catheter incorporates Optical Coherence Tomography (OCT) for imaging, and the "Lightbox Console" has software (version 4.4.0). The device is characterized as "OCT-assisted orientation and imaging" with the system acting "as an adjunct to fluoroscopy." This implies human interaction/interpretation of the OCT images for directional atherectomy. Therefore, a purely standalone algorithm without human-in-the-loop performance cannot be definitively inferred from this document as the primary mode of operation. The "Imaging Capabilities" section describes the system as one to "facilitate atherectomy" and "identify clinically relevant morphologies," which suggests human interpretation of the images provided by the device.
7. The Type of Ground Truth Used
- Mechanical Testing: Ground truth is established by engineering specifications, standardized test methods (e.g., BS EN 1707:1997, ISO 10555-1:2013), and direct physical measurement/observation against those specifications.
- Animal Testing: Ground truth for safety was established by gross necropsy and histopathology performed by veterinary professionals (implied, though not explicitly stated as "experts"). Ground truth for performance was based on direct observation during the procedure and subsequent evaluation/ranking by the study team.
8. The Sample Size for the Training Set
This document describes a 510(k) submission for a medical device (atherectomy catheter with OCT imaging). It is not an AI/Machine Learning submission where a training set of data for an algorithm would be used in the conventional sense. The "Software Verification and Validation Testing" refers to the Lightbox component's software, but this typically involves testing the software against functional requirements and software design specifications, not training an AI model with a data set. Therefore, a "training set" as understood in AI systems is not applicable to this submission.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, a "training set" for an AI model is not applicable to this submission. The "ground truth" for the device's functional software would be its adherence to documented software requirements and design specifications, established through V&V activities.
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